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inspection (general), microsoft excel .xls .xlsx spreadsheet, records (evidence) and records control, software validation, spreadsheets
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  #1  
Old 30th March 2011, 05:51 PM
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Please Help! Medical Device Inspection Sheets - Excel Spreadsheet Validation

I am in need of information on validating Excel spreadsheets. We are creating inspection sheets where data, dimensions, etc. will be input to release medical devices and drugs.

thanks!

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Old 1st April 2011, 09:58 AM
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Re: Medical Device Inspection Sheets - Excel Spreadsheet Validation

A quick "Bump". My Thanks in advance if anyone can help with this one.

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Old 3rd April 2011, 08:14 AM
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Apple Re: Medical Device Inspection Sheets - Excel Spreadsheet Validation

Let me add few steps we have followed for adopting excel spread sheets.

the extent of validation depends on the purpose/level of use....
(eg.,if you intend to maintain the electronic records of dimensions, inspection details etc., (i.e., "release" decisions are taken based on the electronic copy.)
then the purview will extend to validation of e-signatures, audit trails etc.,)

First need to define the procedure which spread sheet will serve + the way spread sheet will be used.;

Next, demonstrate the steps through which you want to meet above intent/purpose of the spread sheet .(controls from inadvertent changes/modifications, design of formula, usage of spread sheet data etc.,)

Then, put together a protocol to ""test/challenge"" the spread sheet. ( requirements of access controls, maintaining/traceability of data etc.,)

Parallel, define a procedure for handling the activities through excel spread sheets.(handling life cycle activities such as change control, alternative/fall-back mechanism to be used in absence of excel spread sheets, if&where required etc.,)

Further, Am sure you must have googled the activity. Let me know if you have specific areas of concern/queries.

Last edited by v9991; 3rd April 2011 at 08:34 AM.
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